Clinical trial · Interventional
Imaging of the Esophagus Using a SECM Capsule
NCT03546660CI-TRIAL-00096712withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): We are currently working and developing our technology to ensure accurate data collection and safety. We will re-open in the future for recruitment.
Summary
Brief summary (as posted)
The goal of this validation study is to compare Spectrally Encoded Confocal Microscopy (SECM) Tethered Capsule Endoscopy (TCE) diagnosis of Eosinophilic Esophagitis to that of standard of care endoscopic biopsy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Esophagus | — | UNRESOLVED | — |
| Eosinophilic Esophagitis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SECM capsule | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SECM capsule imaging
- description
- Participant will swallow the SECM capsule and the imaging of the esophagus will be performed using a SECM optical system
- interventionNames
- Device: SECM capsule
Primary outcomes (1)
- measure
- Feasibility of imaging of the Esophagus using a SECM Capsule
- timeFrame
- 10 minutes (roughly the amount of time it takes to image the esophagus via SECM capsule)
- description
- comparing SECM imaging of the esophagus obtained with a SECM capsule to histopathology.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
Show eligibility criteria text
Inclusion Criteria: * Participants 18 years of age or older who are healthy and have no significant health related issues * Participants 14 years of age of older who are undergoing evaluation for EoE * Able to give informed consent or assent as per the age of the subject Exclusion Criteria: * Inability to swallow pills and capsules * Esophageal fistula and/or esophageal strictures with a stricture diameter that is smaller than the diameter of the capsule
References
Publications (0)
Data not yet available
No reference posted for this study.